The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) (OCTOBER)

European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Heart Disease; Ischaemic Heart Disease
• Intervention / Treatment: Procedure: Angiographic guided PCI; Procedure: OCT guided PCI

Detailed Description

Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.

It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.

Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.

Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.

Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).

• Study Type: Interventional
• Enrollment (Actual): 1201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg (ZOL) Genk
  • Leuven, Belgium, 3000
    • Leuven University Hospital
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital Skejby
  • Gentofte Municipality, Denmark, 2820
    • Gentofte Hospital
  • København Ø, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Zealand University Hospital, Roskilde Sygehus
• Estonia
  • Tallinn, Estonia, 13419
    • Estonia Medical Centre
• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital
• Germany
  • Hamburg, Germany, 20246
    • Universitäres Herzzentrum Hamburg
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10249
      • Vivantes Klinikum im Friedrichshain
• Ireland
  • Galway, Ireland, H91YR71
    • University Hospital Galway
• Italy
  • Rome, Italy, 00168
    • Gemelli General Hospital, Catholic University of the Sacred Heart
  • Cona
    • Ferrara, Cona, Italy, 44124
      • Azienda Ospedaliero-Universitaria di Ferrara
• Latvia
  • Riga, Latvia, LV-1002
    • Latvia Centre of Cardiology
• Netherlands
  • Alkmaar, Netherlands, 1815
    • Northwest Hospital Alkmaar
  • Amsterdam, Netherlands, 1081 HV
    • VU University Medical Center (VUMC)
  • Nieuwegein, Netherlands, 3435 CM
    • St Antonius Ziekenhuis
• Norway
  • Arendal, Norway, 4604
    • Hospital of Southern Norway, Arendal
  • Bergen, Norway
    • Haukeland University Hospital, Bergen
  • Oslo, Norway, 0424
    • Oslo University Hospital, Rikshospitalet
  • Oslo, Norway, 0450
    • Oslo University Hospital - Ullevål
  • Trondheim, Norway
    • Trondheim University Hospital
• Poland
  • Warsaw, Poland, 02-097
    • Medical University of Warsaw
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Stockholm, Sweden, 118 83
    • Södersjukhuset
  • Örebro, Sweden, 70185
    • Orebro University Hospital
  • Stockholm County
    • Huddinge, Stockholm County, Sweden, 14157
      • Karolinska University Hospital Huddinge
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast Health and Social Care Trust
  • Bournemouth, United Kingdom, BH77DW
    • Royal Bournemouth Hospital
  • Brighton, United Kingdom, BN2 5BE
    • Sussex Cardiac Centre
  • Glasgow, United Kingdom, G81 4DY
    • Golden Jubilee Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • Manchester, United Kingdom, M239LT
    • University Hospital South Manchester, Wythenshawe Hospital
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
• Age ≥18 yrs.
• Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.

Angiographic inclusion criteria:

• Native coronary bifurcation de novo lesion
• More than 50% diameter stenosis in the main vessel (MV)
• More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
• Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.

Functional inclusion criteria:

Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.

Procedural inclusion criteria:

Indication for two-stent technique or one-stent technique with kissing balloon inflation

Exclusion Criteria:

• STEMI within 72 hours
• Cardiogenic shock
• Prior coronary artery bypass grafting (CABG) or planned CABG
• Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
• Active bleeding or coagulopathy
• Life expectancy < 2 years
• Ejection fraction < 30%
• New York Heart Association (NYHA) class > II
• Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Angiographic exclusion criteria:

• Severe tortuosity around target bifurcation
• Chronic total occlusions
• Massive thrombus in Left main coronary artery
• Medina 0.0.1 lesions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiographic guided PCI; Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).	Procedure: Angiographic guided PCI; Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques; Other Names: PCI, percutaneous transluminal coronary angioplasty (PTCA)
Experimental: OCT guided PCI; OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)	Procedure: OCT guided PCI; OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans; Other Names: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined endpoint of major adverse cardiac events (MACE)	Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	1 month
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	12 months
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	24 months
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	36 months
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	48 months
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	60 months
All-cause mortality	Death of any cause including cardiac deaths and non-natural causes of death	120 months
Myocardial infarction	Procedure and non-procedure related myocardial infarction	1 month
Myocardial infarction	Procedure and non-procedure related myocardial infarction	12 months
Myocardial infarction	Procedure and non-procedure related myocardial infarction	24 months
Myocardial infarction	Procedure and non-procedure related myocardial infarction	36 months
Myocardial infarction	Procedure and non-procedure related myocardial infarction	48 months
Myocardial infarction	Procedure and non-procedure related myocardial infarction	60 months
Stent Thrombosis	Definite, possible or probable	1 month
Stent Thrombosis	Definite, possible or probable	12 months
Stent Thrombosis	Definite, possible or probable	24 months
Stent Thrombosis	Definite, possible or probable	36 months
Stent Thrombosis	Definite, possible or probable	48 months
Stent Thrombosis	Definite, possible or probable	60 months
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	1 month
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	12 months
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	24 months
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	36 months
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	48 months
Target lesion myocardial infarction	Myocardial infarction related to an index treated lesion	60 months
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	1 month
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	12 months
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	24 months
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	36 months
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	48 months
Target bifurcation myocardial infarction	Myocardial infarction related to the index bifurcation	60 months
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	1 month
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	12 months
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	24 months
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	36 months
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	48 months
CCS angina class	Canadian Cardiovascular Society (CCS) grading of angina pectoris	60 months
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	1 month
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	12 months
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	24 months
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	36 months
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	48 months
Study bifurcation oriented composite endpoint	Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation	60 months
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	1 month
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	12 months
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	24 months
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	36 months
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	48 months
Patient oriented composite endpoint	Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke	60 months
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	1 month
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	12 months
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	24 months
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	36 months
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	48 months
Cardiac death	Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes	60 months
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	1 month
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	12 months
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	24 months
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	36 months
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	48 months
Target lesion revascularisation	Coronary artery bypass grafting or PCI of target lesion	60 months
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	1 month
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	12 months
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	24 months
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	36 months
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	48 months
Target bifurcation revascularisation	Coronary artery bypass grafting or PCI of target bifurcation	60 months
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	1 month
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	12 months
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	24 months
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	36 months
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	48 months
Target vessel revascularisation	Coronary artery bypass grafting or PCI of target vessel	60 months
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	1 month
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	12 months
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	24 months
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	36 months
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	48 months
Any revascularisation	Any repeat revascularization except staged revascularization planned during the index procedure	60 months
Contrast volume	Contrast volume	Baseline, after final baseline procedure
Procedure time	Procedure time	Baseline, after final baseline procedure
Fluoroscopy time	Fluoroscopy time	Baseline, after final baseline procedure
Number of stents implanted in target lesion	Number of stents implanted in target lesion	Baseline, after final baseline procedure
Number of stents implanted in non-target lesion	Number of stents implanted in non-target lesion	Baseline, after final baseline procedure
Total stent length in target lesion	Total stent length in target lesion	Baseline, just after final baseline procedure
Total stent length in total	Total stent length in total	Baseline, just after final baseline procedure
Procedural success	TIMI III flow and less than 30% diameter stenosis in target segments	Baseline, just after final baseline procedure
OCT-guiding group: Successful final OCT acquisition in MV	For OCT-guided enrollments. Successful final OCT acquisition in main vessel. Success defined as analyzable stented segment.	Baseline, just after final baseline procedure
OCT-guiding group: Successful final OCT acquisition in SB	For OCT-guided enrollments. Successful final OCT acquisition in side branch. Success defined as analyzable stented segment.	Baseline, just after final baseline procedure
OCT-guiding group: Successful treatment specific OCT acquisitions	OCT performed succesfully in protocol-defined vessels at all protocol-defined time-points during baseline procedure	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented proximal main vessel segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented distal main vessel segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the treated side branch vessel segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the proximal main vessel edge segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the distal main vessel edge segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the side branch vessel edge segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the stented bifurcation core segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented proximal main vessel segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented distal main vessel segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment	Baseline, after final baseline procedure
Post-PCI diameter stenosis in the treated side branch vessel segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment	Baseline, after final baseline procedure
Post-PCI diameter stenosis in the proximal main vessel edge segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the distal main vessel edge segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the side branch vessel edge segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented bifurcation core segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented distal main vessel ostium segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the treated side branch ostium segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment	Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target stented segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)	Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment	Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target stented segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target proximal edge segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment	Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target distal edge segment	Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment	Baseline, just after final baseline procedure

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Abbott
• Investigators: Study Chair: Evald H Christiansen, MD, PhD, Aarhus University Hospital

Publications and helpful links

General Publications

• Holm NR, Andreasen LN, Walsh S, Kajander OA, Witt N, Eek C, Knaapen P, Koltowski L, Gutierrez-Chico JL, Burzotta F, Kockman J, Ormiston J, Santos-Pardo I, Laanmets P, Mylotte D, Madsen M, Hjort J, Kumsars I, Ramunddal T, Christiansen EH. Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER). Am Heart J. 2018 Nov;205:97-109. doi: 10.1016/j.ahj.2018.08.003. Epub 2018 Aug 16.
• Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): March 25, 2022
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Angioplasty; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Myocardial Revascularization; Cardiac Surgical Procedures; Percutaneous Coronary Intervention; Thoracic Surgical Procedures; Angioplasty, Balloon; Angioplasty, Balloon, Coronary
• Other Study ID Numbers: 1-10-72-161-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Is decided after primary endpoint assessment and requires regulatory approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No